Comparative Exercise-Induced Hypoalgesia in Upper and Lower Limbs: A Randomized Controlled Trial in Healthy Individuals

Phase 1

Recruiting

• Conditions: Healthy Subjects
• Interventions: Other: Aerobic exercise

• Registration Number: NCT06283186
• Lead Sponsor: Centro Universitario La Salle

Brief Summary

This randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb cycle ergometer, another using an upper limb cycle ergometer, and a control group. The exercise protocol involves 30 minutes of aerobic activity at 70-80% of the heart rate reserve. Exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow. Additionally, a secondary objective is to compare the lower limb and upper limb cycle ergometer groups in terms of their effects on pressure pain thresholds in the thigh and elbow. Thus, the study anticipates observing differences in local and distal hypoalgesia based on the trained region.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-28
• Study Start: 2024-04-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria

• Cardiovascular, respiratory, metabolic, neurological, or osteomuscular signs or pathologies.
• History of epilepsy.
• Pregnant
• Pharmacological treatment.
• Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 12 weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upper limb cycle ergometer	Aerobic exercise	The participants in the upper limb cycle ergometer group will undergo a 30-minute aerobic exercise intervention comprising a 5-minute warm-up, 20 minutes of training at 70-80% of the heart rate reserve, and a 5-minute cool-down.
Lower limb cycle ergometer	Aerobic exercise	The participants in the lower limb cycle ergometer group will undergo a 30-minute aerobic exercise intervention comprising a 5-minute warm-up, 20 minutes of training at 70-80% of the heart rate reserve, and a 5-minute cool-down.

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle	Three measurementes: before, immediately after intervention, and 30 minutes after intervention	PPT is tested on the muscle belly of the quadriceps on the dominant side, 10 centimeters cranial to the superior pole of the patella, and on the muscle belly of the epicondyle muscles on the dominant side, 5 centimeters caudal to the epicondyle. The region to be pressed is marked with a pen. The patient is instructed to report the first appearance of the sensation of "discomfort". An ascending ramp of 0.5 kg/cm/s is applied, at the rhythm of a metronome. The measurement is started on the quadriceps and alternated with the epicondyle until 3 measurements of each region are obtained. Each measurement in the same region is obtained after 30 seconds of rest. This protocol has demonstrated high inter-observer reliability measuring healthy subjects (ICC = 0.91).

Secondary Outcome Measures

Name	Time	Method
International Physical Activity Questionnaire (IPAQ)	Before intervention (up 5 minutes)	7-item questionnaire on the level of physical activity at different intensities (high, moderate, and low) and hours sitting. A higher score means higher weekly physical activity.
Heart rate	During intervention (up 30 minutes)	Heart rate will be measured during the procedure by a Polar H10 sensor and a Polar Ignate WR 30M watch.
Rate of perceived exertion (RPE)	Immediately after intervention (up 10 seconds)	RPE Borg CR-10 is used to measure how hard your body works during physical activity. It runs from 0 - 10, using numbers to rate how much effort an activity takes.
Physical Activity Readiness Questionnaire (PAR-Q)	Before intervention (up 5 minutes)	7-item questionnaire that assesses an individual's readiness to engage in physical activity based on whether any known contraindications have been ruled out by the participant. If all the questions are negative, the participant can safely engage in a physical activity.
Fatigue Assessment Scale (FAS)	Before intervention (up 5 minutes)	10-item questionnaire that allows for the evaluation of the participant's current level of fatigue. A higher score means higher fatigue.

Trial Locations

Locations (1)

CSEU LaSalle; 🇪🇸 Madrid, Spain